Women aged 18 to 55 years who had more than two years of chronic pelvic pain that caused disruption to their daily activities

Women were excluded if they were breastfeeding, pregnant or desiring pregnancy during the study period, were unwilling to use contraception during the study period or had previously received botulinum toxin type A injections to the pelvic floor. Palpable pelvic pathology, current use of aminoglycoside antibiotics, history of neurological or bleeding disorders and known sensitivity to the formulation of botulinum toxin type A were also reasons for exclusion

Interventions

Women were randomly assigned to receive 80 units of botulinum toxin type A at a concentration of 20 units/mL or saline injections (placebo group)

FU 26 weeks after injections

Outcomes

VAS, EuroQOL-5D (EQ-5D), SF-12, Sexual Activities Questionnaire

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer-generated sequence

Allocation concealment (selection bias)

Low risk

Central telephone randomisation

Blinding of participants and personnel (performance bias) All outcomes

Blinding of participants and personnel (performance bias) All outcomes

Low risk

Double-blinded

Blinding of outcome assessment (detection bias) All outcomes

Unclear risk

It was recognised that the women might know whether they were receiving MPA because of its effect on their menstrual cycle. Therefore, all were told that both treatments— MPA and placebo—could induce amenorrhoea or irregular vaginal bleeding or have no obvious effect. In addition, women were asked to stop all forms of hormonal or intrauterine contraception and to use barrier methods throughout the 13 months of the trial

Incomplete outcome data (attrition bias) All outcomes

High risk

Of 102 women, 84 completed the full study (18% attrition). Of the other 18 women, 12 withdrew during the treatment period and six during the follow-up. Reasons cited were pregnancy, failure to attend the clinic and inability to maintain trial protocol

Blinding of participants and personnel (performance bias) All outcomes

Unclear risk

Not possible because of the nature of the study

Blinding of outcome assessment (detection bias) All outcomes

Low risk

Outcome assessed blind to allocation

Incomplete outcome data (attrition bias) All outcomes

Unclear risk

Of 100 randomly assigned, 10 failed to attend for follow-up

Selective reporting (reporting bias)

Low risk

All outcomes reported

Other bias

Low risk

Nil

Haugstad 2008

Methods

Randomised trial

Participants

Women between the ages of 20 and 50 years with deep pelvic pain lasting between one and 10 years

Interventions

Treatment group received 10 treatment sessions with the Mensendieck therapist (Haugstad 2007) of one hour’s duration over 90 days, and the control group received standard gynaecological advice at inclusion and again during the treatment period. This therapeutic approach can be seen as a mixture of physiotherapy and psychotherapy. It teaches patients to change their posture, breathing patterns and the way they move to reduce their pain. It uses a cognitive approach to allow women to have an improved understanding and experience of their body

Treatment period: three months

FU: one year

16 study groups, 18 controls

Outcomes

VAS, GHQ-30

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not stated

Allocation concealment (selection bias)

Low risk

Randomisation occurred by drawing a folded piece of paper with the participant's name from a jar, thus allocating the name to a previously chosen treatment group. Randomisation was performed by a person external to the study

Blinding of participants and personnel (performance bias) All outcomes

Low risk

Not possible in this case, unclear whether assessors blinded

Blinding of outcome assessment (detection bias) All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias) All outcomes

High risk

No attrition figures stated, but at one year, only 13 women in each group had completed the questionnaires

Treatment: The participant lay in a prone position; the physician placed his index finger deep into the participant's rectum, and previously identified painful structures were treated in the following order: At a point two finger-widths lateral of the sacrum, the physician used his index finger to exert strong pressure against the sacrotuberous/spinal ligaments for 15 s to elicit pain. Thereafter, the musculature of the pelvic floor and the joint between the coccyx and the sacrum were concurrently forcefully distended dorsally for 60 s with the index finger. This procedure was repeated after two to three weeks

Control: standard care (counselling)

Duration: four to six weeks

Outcomes

VAS

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Randomisation method not stated

Allocation concealment (selection bias)

Low risk

By drawing an envelope, assignment to treatment or control group was performed in blocks of four (i.e. the number of participants in each group was balanced after each fourth participant)

Blinding of participants and personnel (performance bias) All outcomes

High risk

Blinding not possible, unclear whether assessors blinded

Blinding of outcome assessment (detection bias) All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias) All outcomes

High risk

Three of 25 (> 10%) dropped out from each group

Selective reporting (reporting bias)

Low risk

All outcomes reported

Other bias

Low risk

Nil

Norman 2004

Methods

Method of allocation: randomly assigned in blocks of two

Power calculation: no

Intention-to-treat analysis: no

Participants

Country: United States

Number of participants: 48 (28 disclosure, 20 control)

Age: 18 to 64

Sex: F

Interventions

Treatments: Two groups of women wrote about their positive (control group) and their negative (disclosure group) experience of pain and had their health status assessed at the end of two months

Outcomes

McGill Pain Questionnaire

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

'Randomised in blocks of 2' into sealed packets

Allocation concealment (selection bias)

Unclear risk

Not stated

Blinding of participants and personnel (performance bias) All outcomes

Exclusion criteria: no malignancy/disease requiring prompt gynaecological intervention, no history of psychiatric/psychotherapeutic treatment for abdominal pain, no elaborate medical analysis re abdominal pain in the past two years

Blinding of participants and personnel (performance bias) All outcomes

High risk

Blinding not possible, but unclear whether assessors blinded

Blinding of outcome assessment (detection bias) All outcomes

Low risk

Outcome assessor blind to allocation

Incomplete outcome data (attrition bias) All outcomes

Low risk

No dropouts

Selective reporting (reporting bias)

Low risk

All outcomes reported

Other bias

Low risk

Nil

Sator-Katzenschlager 2005

Methods

Randomisation methods not specified

Participants

CPP longer than six months

Interventions

Gabapentin (n = 20), amytriptyline (n = 20) or combination (n = 16)

Dose of amytriptyline was increased from an initial dose of 25 mg per day up to a maximum dose of 150 mg per day in 25-mg increments each week until sufficient pain relief or the occurrence of side effects such as somnolence, dizziness, orthostatic hypotension, palpitations, dry mouth and weight gain. The dose of gabapentin was increased from 300 mg per day up to a maximum dose of 3600 mg per day in 300-mg increments each week until sufficient pain relief or the occurrence of side effects

Outcomes

VAS

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not stated

Allocation concealment (selection bias)

Unclear risk

Not stated

Blinding of participants and personnel (performance bias) All outcomes

High risk

Not blinded as open-label trial, unclear whether assessors blinded

Blinding of outcome assessment (detection bias) All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias) All outcomes

High risk

Seven participants dropped out because of side effects; > 10% dropout

Selective reporting (reporting bias)

Low risk

All outcomes reported

Other bias

Unclear risk

Seven participants excluded after randomisation, so not analysed by intention-to-treat, but same number of dropouts from gabapentin (three) or amytriptyline group (three)

Note high dropout rate in treatment group (nine of 19 completed eight weeks of treatment)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "Women were randomised using a sealed envelope system to receive lofexidine hydrochloride or placebo''

Allocation concealment (selection bias)

Low risk

Sealed envelope

Blinding of participants and personnel (performance bias) All outcomes

Low risk

Double-blinded, unclear whether assessors blinded

Blinding of outcome assessment (detection bias) All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias) All outcomes

High risk

High dropout rate, > 10% dropout

Selective reporting (reporting bias)

Low risk

All outcomes reported

Other bias

Low risk

Nil

Walton 1992

Methods

Methods of allocation: not stated.

Blinding: not stated

Exclusion postrandomisation: zero

Participants

Country: UK

Number of participants: 165

Age: not given

Sex: F

Inclusion criteria: pelvic pain for longer than six months

No pathology on laparoscopy

Exclusion criteria not given

Interventions

Treatment: medroxyprogesterone acetate 50 mg daily

Control: placebo tablets

Duration: four months

Follow-up: only until end of treatment

Outcomes

Visual analogue scale pain score

Pain improvement rating: better/not better

Notes

Note very high dropout rate in MPA and placebo groups. Published report does not give SD for mean VAS, so data entered in Table are the numbers reporting 50% reduction in VAS at completion of the study. This allowed comparison with Farquhar 1989, as the drug, dose and duration of therapy are the same. Complete study report obtained by the review authors

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "Two patients were allocated, at random, to the treatment group for each one given placebo"

Allocation concealment (selection bias)

Unclear risk

Not stated

Blinding of participants and personnel (performance bias) All outcomes

Unclear risk

Not stated

Blinding of outcome assessment (detection bias) All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias) All outcomes

High risk

High dropout rate, reasons obtained; commonest is non-compliance; losses to follow-up: 64% of those taking active drug and 57% of those taking placebo completed the study

Selective reporting (reporting bias)

Low risk

All outcomes reported

Other bias

Low risk

Nil

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Brown 2008

Open-label trial. Lack of placebo control group, lack of randomisation

Elcombe 1997

Participants entered and evaluated at different time points in control and active groups, making comparison between groups difficult

Fenton 2008

Cross-over trial with no washout period

Onwude 2004

Includes surgery

Pearce 1986

Abstract only. No data available

Reginald 1987

Not an RCT

Simsek 2007

Randomised cross-over trial without washout period

Characteristics of studies awaiting assessment [ordered by study ID]

Horne 2012

Methods

Randomised controlled trial (pilot feasibility study)

Participants

n = 60 women recruited from NHS UK hospital

Interventions

Women randomly assigned to gabapentin versus placebo

Outcomes

Primary objective is to assess recruitment and retention rates. Secondary objectives are to determine the effectiveness and acceptability to participants of proposed methods of recruitment and randomisation, drug treatments and assessment tools and to perform a pretrial cost-effectiveness assessment of treatment with gabapentin

*The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).CI: Confidence interval; OR: Odds ratio.

GRADE Working Group grades of evidence.High quality: Further research is very unlikely to change our confidence in the estimate of effect.Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.Very low quality: We are very uncertain about the estimate.

140% dropout rate in one of the two studies.2> 10% dropout rate.3Wide confidence intervals compatible with no effect or with higher rates of improvement in placebo group.

Improvement in mean pelvic pain score in the goserelin group was three points greater than in the progestogen group (95% CI 2.08 higher to 3.92 higher)

47(one study)

⊕⊕⊕⊝moderate1

Improvement in pelvic pain score measured on a scale of one to 100

Pain at 24 months: gabapentin versus amytriptyline

Mean pain score in the gabapentin group was 1.5 points lower than in the amytriptyline group (95% CI 2.06 lower to 0.94 lower)

40(one study)

⊕⊕⊝⊝low1,2

Pain score measured on a VAS scale of zero to 10

CI: Confidence interval.

GRADE Working Group grades of evidence.High quality: Further research is very unlikely to change our confidence in the estimate of effect.Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.Very low quality: We are very uncertain about the estimate.

1Participants not blinded.2> 10% attrition.

Summary of findings 3. Psychological therapy compared with control interventions for the management of chronic pelvic pain

Psychological therapy compared with control interventions for the management of chronic pelvic pain

Improvement considered an improvement of at least one point on a zero to five pain scale

Improvement in pain scores—Psychotherapy versus placebo, measured at end of treatment

320 per 1000

271 per 1000(101 to 549)

Peto OR 0.79 (0.24 to 2.59 )

51(one study)

⊕⊕⊕⊝low10,11

Improvement defined as ≥ 50% reduction in VAS pain score

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).CI: Confidence interval.

GRADE Working Group grades of evidence.High quality: Further research is very unlikely to change our confidence in the estimate of effect.Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.Very low quality: We are very uncertain about the estimate.

110% attrition.2Sequence generation method not described.3No attrition figures stated, but at one year, only 13 women in each group had completed the questionnaires.4Unblinded.5Wide confidence intervals compatible with no effect or with benefit from intervention.6Participants not blinded.720% loss to follow-up.8Allocation concealment methods not described.9Unclear whether participants blinded.10Wide confidence intervals compatible with no effect or with increased pain from intervention.1118% attrition.

Summary of findings 4. Complementary therapy compared with control interventions for the management of chronic pelvic pain

Complementary therapy compared with control interventions for the management of chronic pelvic pain

Mean reduction in pain score in the intervention group was 35.8 higher (23.08 higher to 48.52 higher)

-

48(one study)

⊕⊕⊕⊝moderate1

Reduction in pain score, measured on a self assessed one to 100 VAS scale

Pain score after treatment: magnetic therapy versus control magnet

11

Mean pelvic pain score in the intervention group was 0.5 lower (1.92 lower to 0.92 higher)

-

19(one study)

⊕⊝⊝⊝very low2,3

Post-treatment pelvic pain score on a zero to five-point scale, where 0 = no pain and 5 = excruciating pain

*The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).CI: Confidence interval.

GRADE Working Group grades of evidence.High quality: Further research is very unlikely to change our confidence in the estimate of effect.Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.Very low quality: We are very uncertain about the estimate.

1Unclear whether blinded, 12% attrition.241% dropout rate at two to four weeks.3Wide confidence interval compatible with no effect or benefit from magnetic therapy.